MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stacking Breaths (1593); Headache (1880); Pain (1994); Burning Sensation (2146); Numbness (2415); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported that the patient underwent an anterior cervical fusion surgery at c5-6 on (b)(6) 2012 using rhbmp-2/acs.The patient's post-operative period was marked by severe and chronic pain, cervical radiculopathy, lost function of right upper extremity, numbness in right arm, burning in right arm, shortness of breath, brain welling, cannot lift arm without extreme pain, arm weakness, headache, and neck pain.Patient is treated now with medications, pain management, pain patches.

Manufacturer Narrative

(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2012 the patient underwent: c5-6 anterior cervical discectomy and fusion with machined allograft interbody spacer and anterior instrumentation.Preoperative diagnosis: c5-6 cervical disc herniation and cervical radiculopathy.Per-op notes: ¿the epidural space was probed and no other loose fragments could be identified.The wound was irrigated, a 7mm lordotic machined allograft cortical interbody spacer was filled with a quarter sponge of rhbmp-2 and impacted on the disc space, local bone from the approach was placed anterior to the graft.Locking mechanism was then engaged in the screw heads.¿.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3746578
• MDR Text Key: 4418604
• Report Number: 1030489-2014-02173
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other